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510(k) K881879

ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 by Alpha-Tec Systems, Inc. — Product Code JSK

K881879 is an FDA 510(k) premarket notification submitted by Alpha-Tec Systems, Inc. for the device "ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42". The FDA issued a decision of Substantially Equivalent on May 13, 1988. The device falls under product code JSK (Supplement, Culture Media), a Class I device regulated under 21 CFR 866.2450. Alpha-Tec Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
May 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Supplement, Culture Media
Device Class
Class I
Regulation Number
866.2450
Review Panel
MI
Submission Type

Other clearances by Alpha-Tec Systems, Inc.

  • K053257 — PARA-PRO FC50 (May 12, 2006)
  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K890148 — ATS TB RAPID STAIN SET PRODUCT #034-45 (January 24, 1989)
  • K890022 — ATS MAYER'S ALBUMIN (January 10, 1989)
  • K883048 — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (August 17, 1988)
  • K883049 — ATS PARA-SET IODINE ALCOHOL SOLUTION (August 17, 1988)
  • K883062 — ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID (August 4, 1988)
  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K880989 — ATS CRYPTOSPORIDIUM STAIN SET (May 13, 1988)

Other clearances for product code JSK

  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K881566 — HEMOGLOBIN POWDER (April 18, 1988)
  • K861997 — PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (June 10, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K855172 — KWI (TM) G-CO/TWO (February 20, 1986)
  • K853546 — ABBOTT CATION SUPPLEMENT SOLUTION (September 6, 1985)
  • K850302 — SUPLEX & SUPLEX DILUENT (March 22, 1985)
  • K850300 — MUCOLYSE (March 20, 1985)

FDA data resources